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SCHEDULE Y · PHARMACOVIGILANCE INTAKE
New adverse-event report
23:47
REGULATORY SLA · h:m
1
Patient identification
Auto-prefilled from active call · verify before submittingPatient MRN *
⤴ AUTO-PREFILLED FROM CALL CONTEXT
Initials
Age
Sex
Weight / height
Pregnancy status
2
Adverse event description
Capture patient's own words verbatim — translate afterVerbatim description (in patient's words) *Required in original language. Hindi/regional accepted.
SOURCE: VOICE CALL TRANSCRIPT · 13:11 IST · NLP-FLAGGED
English translationFor regulatory submission
Event onset date *
Event onset time
Outcome *
Date of recovery
MedDRA preferred-term codingAuto-suggested from verbatim
SOCMetabolism and nutrition disorders10027433
HLTHypoglycaemic conditions NEC10020993
PTHypoglycaemia, symptomatic10020994
★ AUTO-MATCHED · 96% confidence
3
Severity & seriousness
Determines escalation path · Schedule Y triggersSeverity *Clinical impact on patient
Mild
no intervention needed
Moderate
required intervention
Severe
hosp. or disability
Life-threat.
imminent risk of death
Seriousness criteria (Schedule Y)Tick all that apply · any tick = serious AE
Flagged as SERIOUS AE — required 3rd-party (wife) intervention for symptom relief. This triggers the 15-calendar-day expedited reporting path to CDSCO & Novo Nordisk safety.
4
Suspect medication
Drug exposure details · auto-prefilled from prescription recordSuspect drug *
Manufacturer
Indication
Batch / lot no.
Dose at time of event
Route
Date started on this dose
Time on drug at event
Action taken with suspect drugFollowing the event
Concomitant medications
Metformin XR 1000 mg BD · Empagliflozin 10 mg OD · Atorvastatin 20 mg HS · Telmisartan 40 mg OD
Edit →
5
Causality assessment
WHO-UMC scale · MD review will reconfirmWHO-UMC category *Initial assessment by reporter (coach) · MD will finalise
| Certain | Plausible time, definitive rechallenge positive, well-defined pharmacology | |
| Probable / Likely | Reasonable time, unlikely to be attributed to disease/other drugs, improvement on withdrawal | |
| Possible | Reasonable time, could be explained by disease or other drugs | |
| Unlikely | Improbable time-to-onset, other plausible cause | |
| Conditional / Unclassified | More data needed for assessment | |
| Unassessable | Contradictory or insufficient data; cannot be supplemented |
Rationale (coach note): Symptoms began 15 h after up-titration from 22→26 U · symptoms resolved with oral carbohydrate · pharmacology consistent with hypoglycaemia · no alternative cause identified.
6
Reporter information
Initial reporter *
Source of report
Treating physician
MD review required
Programme
Country of incident
✓
CIOMS-I preview
This is what will be exported to Novo Nordisk safety & CDSCOSuspect Adverse Reaction Report · CIOMS-I
1. PATIENT INITIALSS.B.
1A. COUNTRYIndia
2. DATE OF BIRTH / AGE58 yr · male
3. SEXMale
7. DESCRIBE REACTION(S)Symptomatic hypoglycaemia following up-titration of insulin Ryzodeg 70/30 from 22 to 26 units. Patient experienced dizziness, sweating, hand-trembling at ~22:30 and again at 10:00 next day. Symptoms resolved with oral carbohydrate within ~30 min. Required 3rd-party (spouse) assistance.
8–12. SERIOUSNESSMedically significant; required intervention
13. CHECK ALL APPROPRIATE☑ Required Intervention to Prevent Permanent Impairment
14. SUSPECT DRUGRyzodeg 70/30 (insulin degludec / insulin aspart) · 26 U OD SC · Indication: T2DM · Date started: 12 May 2026 (titrated from 22 U) · Action: dose reduced
17. CONCOMITANT DRUGSMetformin XR 1000 BD; Empagliflozin 10 OD; Atorvastatin 20 HS; Telmisartan 40 OD
22. CAUSALITYProbable (WHO-UMC)
24. REPORTER NAME & ADDRESSPriya R. · Senior Care Coach · Diabeasy / Caresoft Systems · Mumbai, India · priya.r@diabeasy.in
25. REPORT TYPEInitial · expedited (15-day)
DATE OF REPORT12 May 2026
CIOMS-I template · v2024.3 · CASE-AE-26-0090